|By Marketwired .||
|November 5, 2012 05:30 PM EST||
LOS ANGELES, CA -- (Marketwire) -- 11/05/12 -- The Medicines Company (NASDAQ: MDCO) announced today the first presentation of PRONTO, a study of emergency patients with acute heart failure associated with high blood pressure enrolled within hours of their hospital arrival, making it the earliest examination of acute heart failure treatment ever performed in a clinical trial. More than 1 million acute heart failure patients each year present -- mainly to emergency departments -- at US hospitals. About half of these have high blood pressure.
The primary objective and the main secondary objective of the PRONTO clinical trial were met. Patients randomized to early treatment with Cleviprex® (clevidipine) Injectable Emulsion demonstrated more rapid and greater blood pressure reductions (p-value < 0.001). Patients reported that shortness of breath, their most distressing symptom, resolved more rapidly than with the current standard of care (SOC) (overall p-value 0.037). Safety measures were similar for both randomized treatments.
These findings were presented by W. Frank Peacock IV, MD, FACEP, Emergency Medicine Research Director at Baylor College of Medicine and Principal Investigator for PRONTO on behalf of a group of leading international acute heart failure investigators and discussed during the "Clevidipine Improves Dyspnea in Emergency Department Acute Heart Failure: A Randomized, Open Label Study" presentation (abstract 15606), presented today at the American Heart Association Scientific Sessions 2012 in Los Angeles, California.
PRONTO Purpose and Potential Implications
Dr. Peacock discussed why he is particularly excited about the data: "PRONTO was the first major heart failure trial in the last decade that displayed a significant improvement in dyspnea vs. SOC." Dr. Peacock added, "Dyspnea is the number one reason heart failure patients go to the hospital and stay there. An agent that can relieve dyspnea may have the potential to decrease associated length of stay and hospital costs as well as improve the quality of life for patients. The faster we can improve their breathing, the sooner they can go home." Of the more than 1 million patients admitted to hospitals for heart failure each year, the mean length of stay is nearly 5 days. The costs associated with these patients' hospitalizations is estimated at approximately $40 billion annually in the US.1
Gregg C. Fonarow, MD, FACC, Professor of Medicine, Ahmanson-UCLA Cardiomyopathy Center Director, UCLA Division of Cardiology Co-Chief and PRONTO Steering Committee member, noted potentially important clinical implications in the PRONTO data: "According to the findings, clevidipine treated dyspnea better than established standard of care therapies. This challenges previously held paradigms that calcium channel antagonists should be avoided in patients with acute heart failure. Further trials are needed to corroborate these findings, but clevidipine may provide an attractive treatment option to reduce blood pressure and improve breathing for acute heart failure patients who are hypertensive."
PRONTO Study Methods, Results and Limitations
A randomized open-label, multi-center trial, PRONTO (A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure -- A Pilot Study), enrolled 104 emergency department hypertensive acute heart failure patients who exhibited pulmonary congestion. After setting a 30-minute target systolic blood pressure (SBP) range, patients were randomly treated with clevidipine or SOC (predominantly nitroglycerin and nicardipine), each administered per approved labeling.
In this trial, clevidipine met the composite primary endpoint of median time and percent of patients to reach target SBP range and a 15% blood pressure reduction in the first 30 minutes of therapy. Approximately twice as many clevidipine-treated patients achieved this endpoint than SOC-treated patients (70.5 vs. 36.6%). The median time to achieve this endpoint for clevidipine-treated patients was 15 minutes. The median time for SOC treated patients could not be estimated because fewer than 50% of patients achieved the primary endpoint (p=0.0006). The SOC-treated patients that achieved this endpoint did so in a median of 18 minutes.
In addition, clevidipine met the main secondary endpoint: dyspnea reduction (improved breathing). Within 45 minutes, the dyspnea visual analogue scale (VAS) for shortness of breath decreased more from baseline with clevidipine (median -3.6 cm) than with SOC (-2.1 cm), p=0.012. This effect was maintained to 3 hours with overall effect (p=0.037).
The percentage of patients with at least one study drug related treatment-emergent adverse event was similar in the clevidipine (9.8%) and SOC (13.2%) groups. The most common of these events was headache.
Limitations of the trial included its relatively small sample size, powered for the primary but not for all secondary endpoints, and the open label design, which makes subjective dyspnea assessments challenging. The standard of care (SOC) treatment comparator -- while representative of real care -- may have provided an inconsistent control group, although subset analysis did not suggest such confounding.
About Cleviprex® (clevidipine) Injectable Emulsion
Cleviprex (clevidipine) is an intravenous dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. In June 2011, the U.S. Food and Drug Administration (FDA) approved the current formulation, which triples the maximum allowable infusion time per vial, commonly referred to in hospitals as "hang time," to 12 hours compared to the original 4-hour hang time vial approved by the FDA in 2008.
Important Safety Information About Cleviprex (clevidipine)
Cleviprex (clevidipine) is contraindicated in patients with allergies to soybeans, soy products, eggs or egg products; defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if it is accompanied by hyperlipidemia; and severe aortic stenosis.
Cleviprex is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.
Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. If either occurs, decrease the dose of Cleviprex. There is limited experience with short-duration therapy with beta-blockers as a treatment for Cleviprex-induced tachycardia. Beta-blocker use for this purpose is not recommended.
Cleviprex contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism.
Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
Cleviprex is not a beta-blocker, does not reduce heart rate and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.
Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.
There is no information to guide use of Cleviprex in treating hypertension associated with pheochromocytoma.
Most common adverse reactions are ( > 2%) headache, nausea, and vomiting.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the extent of the commercial success of Angiomax, the Company's ability to develop its global operations and penetrate foreign markets, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, risks associated with the establishment of international operations, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 9, 2012, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
1. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics - 2012 update: a report from the American Heart Association. Circulation. 2012;125(1):e2-e220.
The Medicines Company
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
Nov. 23, 2014 11:30 AM EST Reads: 1,206
Verizon Enterprise Solutions is simplifying the cloud-purchasing experience for its clients, with the launch of Verizon Cloud Marketplace, a key foundational component of the company's robust ecosystem of enterprise-class technologies. The online storefront will initially feature pre-built cloud-based services from AppDynamics, Hitachi Data Systems, Juniper Networks, PfSense and Tervela. Available globally to enterprises using Verizon Cloud, Verizon Cloud Marketplace provides a one-stop shop fo...
Nov. 23, 2014 11:00 AM EST Reads: 1,179
Leysin American School is an exclusive, private boarding school located in Leysin, Switzerland. Leysin selected an OpenStack-powered, private cloud as a service to manage multiple applications and provide development environments for students across the institution. Seeking to meet rigid data sovereignty and data integrity requirements while offering flexible, on-demand cloud resources to users, Leysin identified OpenStack as the clear choice to round out the school's cloud strategy. Additional...
Nov. 23, 2014 08:00 AM EST Reads: 1,304
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud strategy and programs. In this Power Panel at 15th Cloud Expo (http://www.CloudComputingExpo.com...
Nov. 23, 2014 07:45 AM EST Reads: 1,383
We are all here because we are sold on the transformative promise of The Cloud. But what good is all of this ephemeral, on-demand infrastructure if your usage doesn't actually improve the agility and speed of your business? How must Operations adapt in order to avoid stifling your Cloud initiative? In his session at DevOps Summit, Damon Edwards, co-founder and managing partner of the DTO Solutions, will highlight the successful organizational, process, and tooling patterns of high-performing c...
Nov. 23, 2014 02:00 AM EST Reads: 1,069
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
Nov. 22, 2014 10:00 PM EST Reads: 1,183
Software-driven innovation is becoming a primary approach to how businesses create and deliver new value to customers. A survey of 400 business and IT executives by the IBM Institute for Business Value showed businesses that are more effective at software delivery are also more profitable than their peers nearly 70 percent of the time (1). DevOps provides a way for businesses to remain competitive, applying lean and agile principles to software development to speed the delivery of software that ...
Nov. 22, 2014 08:00 PM EST Reads: 1,466
Docker offers a new, lightweight approach to application portability. Applications are shipped using a common container format and managed with a high-level API. Their processes run within isolated namespaces that abstract the operating environment independently of the distribution, versions, network setup, and other details of this environment. This "containerization" has often been nicknamed "the new virtualization." But containers are more than lightweight virtual machines. Beyond their small...
Nov. 22, 2014 06:45 PM EST Reads: 1,234
The move in recent years to cloud computing services and architectures has added significant pace to the application development and deployment environment. When enterprise IT can spin up large computing instances in just minutes, developers can also design and deploy in small time frames that were unimaginable a few years ago. The consequent move toward lean, agile, and fast development leads to the need for the development and operations sides to work very closely together. Thus, DevOps become...
Nov. 22, 2014 05:45 PM EST Reads: 1,356
ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ -- IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and asse...
Nov. 22, 2014 05:30 PM EST Reads: 1,180
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
Nov. 21, 2014 09:15 PM EST Reads: 1,296
Technology is enabling a new approach to collecting and using data. This approach, commonly referred to as the "Internet of Things" (IoT), enables businesses to use real-time data from all sorts of things including machines, devices and sensors to make better decisions, improve customer service, and lower the risk in the creation of new revenue opportunities. In his General Session at Internet of @ThingsExpo, Dave Wagstaff, Vice President and Chief Architect at BSQUARE Corporation, discuss the ...
Nov. 21, 2014 08:00 PM EST Reads: 1,367
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
Nov. 21, 2014 08:00 PM EST Reads: 1,313